smith&nephew R3 THREE HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 40MM 71335540 42MM 71335542 44MM 71335544 46MM 71335546 48MM 71335548 50MM 71335550 52MM 71335552 54MM 71335554 56MM 71335556 58MM 71335558 60MM 71335560 Orthopedic implant component.
This recall is currently active, issued April 22, 2020. It was issued by Smith & Nephew Inc.
- Company
- Smith & Nephew Inc
- Recall Initiated
- April 22, 2020
- Recall Number
- Z-2333-2020
- Quantity
- 6468 devices
- Firm Location
- Memphis, TN
- Official Source
- View on FDA website ↗
Reason for Recall
A manufacturing error resulted in out of specification R3 Acetabular Shells
Distribution
Worldwide
Lot / Code Info
71335540, Lot Numbers: 18JM08648, 18JM08650, 18MM12391 71335542, Lot Numbers: 18HM20695, 18LM09821, 19DM12897, 19DM12898, 19DM12899 71335544, Lot Numbers: 18LM02189, 18LM02191, 18LM02192, 18MM08580, 18MM08582 71335546, Lot Numbers: 19AM10686, 19AM07909, 18MM08601, 18HM04443, 18HM04455, 18HM04461, 18HM04474, 18HM04483, 18HM04487, 18HM04488, 18HM04492, 18HM04495, 18HM04926, 18HM19845, 18HM19846, 18HM19848, 18HM19851, 18JM06297, 18JM06307, 18JM06308, 18KM17658, 18KM17659, 18KM17660, 18KM17662, 18MM08596, 18MM08602, 18MM08604, 18MM08607, 18MM08608, 18MM08609, 18MM08610, 18MM11254, 18MM11255, 19AM07907, 19AM07908, 19AM07916, 19AM07922, 18HM04443A, 18HM04455A, 18HM04488A, 18KM17662A, 19AM07922A, 18HM20664 71335548, Lot Numbers: 18LM19747, 19EM11800, 18LM13809, 18JM12746, 18KM09504, 18KM09498, 18KM09497, 19AM15831, 18LM19745, 18KM20266, 18MM14693, 18MM14703, 18MM14704, 18MM14697, 18LM13809A, 18MM01152, 18JM12746A, 18MM14703A, 18KM09502, 18LM13799, 18GM04646, 18GM04651, 18GM04658, 18GM04669, 18GM04677, 18GM04679, 18GM16200, 18GM16201, 18GM16203, 18GM16208, 18GM16210, 18GM16222, 18GM16240, 18GM18532, 18GM18541, 18GM18547, 18GM18567, 18GM18570, 18HM01688, 18HM01700, 18HM01709, 18HM01730, 18HM11151, 18HM11155, 18HM11167, 18HM11185, 18HM11192, 18HM11194, 18HM11207, 18HM19069, 18JM02729, 18JM12750, 18JM12751, 18JM12753, 18JM12760, 18JM12761, 18JM12765, 18JM12768, 18JM12771, 18KM09496, 18KM09501, 18KM09505, 18KM09510, 18KM13647, 18KM13648, 18KM13649, 18KM13650, 18KM13651, 18KM13652, 18KM13654, 18KM13655, 18KM20263, 18KM20264, 18LM00736, 18LM09824, 18LM09827, 18LM09828, 18LM09829, 18LM09835, 18LM09839, 18LM09852, 18LM09853, 18LM13765, 18LM13771, 18LM13774, 18LM13785, 18LM13786, 18LM13794, 18LM13797, 18LM13800, 18LM13814, 18LM19129, 18LM19138, 18LM19139, 18LM19141, 18LM19142, 18LM19749, 18LM19755, 18LM19756, 18LM19760, 18LM19762, 18LM19765, 18LM19771, 18MM02927, 18MM02933, 18MM02938, 18MM09564, 18MM11257, 18MM11260, 18MM11262, 18MM11265, 18MM11266, 18MM11268, 18MM11269, 18MM11275, 18MM14687, 18MM14691, 18MM14692, 18MM14700, 18MM14705, 18MM14708, 18MM14709, 19AM00787, 19AM15799, 19AM15807, 19AM15808, 19AM15834, 19AM15837, 19AM15839, 18GM16201A, 18GM18541A, 18GM18567A, 18HM01688A, 18HM11151A, 18HM11151B, 18JM03521, 18JM12750A, 18KM13649A, 18LM09852A, 18LM09852B, 18LM13771A, 18MM02358, 18MM07668, 18MM14700B, 18KM13650A, 18JM16121, 18KM09505A, 18KM20264A, 18KM13655A, 18MM14700A, 18LM19749A, 18KM20265A 71335550, Lot Numbers: 18MM14715, 18JM16421, 18MM11293, 18JM00837, 18MM11296, 18MM14694, 18MM14713, 18JM04490, 18JM04486, 18JM00844, 18MM14715A, 18JM16421A, 18MM14694A, 18GM06460, 18GM16291, 18GM16291A, 18KM24791, 18LM13776, 18GM06120, 18GM06191, 18GM06248, 18GM06259, 18GM06367, 18GM06374, 18GM06376, 18GM06381, 18GM06384, 18GM06446, 18GM06448, 18GM06454, 18GM06462, 18GM06481, 18GM16261, 18GM16275, 18GM16277, 18GM16281, 18GM18647, 18GM18648, 18GM19999, 18HM12250, 18HM12251, 18HM12291, 18HM12294, 18HM12308, 18HM12311, 18HM12313, 18HM12326, 18HM12367, 18HM12372, 18HM13026, 18HM13027, 18HM13031, 18HM14835, 18HM14852, 18HM14880, 18HM14881, 18HM15459, 18HM15461, 18HM15468, 18HM15484, 18HM15507, 18JM00831, 18JM00833, 18JM00834, 18JM00835, 18JM00838, 18JM04484, 18JM04485, 18JM04487, 18JM04497, 18JM04499, 18JM04897, 18JM04898, 18JM06646, 18KM24783, 18KM24811, 18LM02324, 18LM02325, 18LM02328, 18LM13789, 18MM11294, 18MM11303, 18MM11305, 18MM11309, 18MM14680, 18MM14683, 18MM14686, 18MM14688, 18MM14698, 18MM14701, 18MM14714, 19AM00774, 19AM00779, 19AM00780, 19AM00785, 19AM00789, 19AM00813, 19AM00823, 19AM00824, 19AM00827, 19AM00828, 19AM00830, 19AM00855, 18GM06259A, 18GM16279A, 18GM16281A, 18HM12251A, 18HM12311A, 18HM14852A, 18HM14880A, 18HM15459A, 18HM15507A, 18JM00831A, 18JM00833A, 18LM02325A, 19AM00779A, 18KM16035, 19AM00774A 71335552, Lot Numbers: 19DM00942, 18JM17685, 18KM20295, 18KM00810, 18LM00756, 18KM23741, 18LM00756A, 18GM07455, 18GM20389, 18JM12793, 18JM17688, 18KM06647, 18KM24186, 18LM00752, 18KM06668A, 19AM06152, 18GM20288.18GM20291, 18GM20296, 18GM20309, 18GM20331, 18GM20343, 18HM16439, 18HM16440, 18HM16443, 18HM16444, 18HM16452, 18HM16472, 18HM16489, 18HM16518, 18HM16522, 18HM16528, 18HM16550, 18HM16552, 18HM16553, 18HM16627, 18HM19802, 18HM19822, 18HM19826, 18HM19829, 18HM19835, 18HM19837, 18JM09331, 18JM09332, 18JM09333, 18JM09338, 18JM09339, 18JM09343, 18JM12790, 18JM12795, 18JM12831, 18JM12835, 18JM12858, 18JM12859, 18JM12861, 18JM12869, 18JM17671, 18JM17674, 18JM17683, 18JM17684, 18KM00789, 18KM00825, 18KM06654, 18KM13657, 18KM13659, 18KM13660, 18KM13665, 18KM13666, 18KM13667, 18KM13668, 18KM13685, 18KM13687, 18KM15744, 18KM15746, 18KM15747, 18KM15750, 18KM20307, 18KM20311, 18KM24813, 18KM24815, 18KM24816, 18KM24818, 18LM00739, 18LM02334, 18LM02335, 18LM17954, 18LM17955, 18LM17959, 18LM17965, 18LM17977, 19AM06094, 19AM06098, 19AM06100, 19AM06104, 19AM06111, 19AM06118, 19AM06122, 19AM06125, 19AM06127, 19AM06140, 19AM06141, 19AM06147, 19AM06150, 19AM13012, 19AM13015, 18GM20309A, 18HM16522A, 18HM16522B, 18HM16550A, 18HM16552A, 18HM19802A, 18HM19826A, 18HM19829A, 18HM19835A, 18JM10883, 18JM12859A, 18JM12861A, 18KM05958, 18LM00749A, 18LM02335A, 18LM09352, 18JM09338A, 18KM00790B, 18KM13667A, 18KM17682B, 19AM06104A, 18JM17664, 18JM17689A 71335554, Lot Numbers: 19FM00485, 18JM17714, 18KM26067, 18KM13702, 18KM13726, 18KM13722, 18JM13880, 18KM09537, 18JM13892, 18KM13709, 19AM18491, 18HM00801, 18HM04947, 18HM04957, 18HM04969, 18HM04973, 18HM05002, 18HM05005, 18HM05015, 18HM05019, 18HM05044, 18HM05065, 18HM19077, 18HM19078, 18HM19079, 18HM19082, 18HM19085, 18HM19086, 18HM19087, 18JM13881, 18JM17713, 18JM17715, 18JM17719, 18JM17730, 18KM03153, 18KM03154, 18KM03158, 18KM03161, 18KM09521, 18KM09523, 18KM09525, 18KM09526, 18KM09533, 18KM09538, 18KM09546, 18KM09548, 18KM13706, 18KM13713, 18KM13715, 18KM13719, 18KM13721, 18KM13725, 18KM13728, 18KM13729, 18KM13731, 18KM16116, 18KM16119, 18KM16120, 18KM16130, 18KM26035, 18KM26073, 18KM26078, 18LM05195, 18LM05196, 18LM05199, 18LM05208, 18LM10963, 18LM18558, 18LM18565, 18MM03110, 18MM03115, 18MM07166, 18MM07198, 18MM07208, 18MM07209, 18MM07211, 18MM07212, 18MM07217, 18MM07237, 18MM11338, 19AM07762, 19AM07769, 19AM07772, 19AM07773, 19AM07782, 19AM07783, 19AM18599, 18HM04957A, 18HM05044B, 18HM19085A, 18HM19087B, 18JM19382A, 18KM03154A, 18KM09538A, 18KM13715A, 18KM16119A, 18JM15275, 18JM18174, 18JM19382, 18KM09521A, 18KM13711A, 18KM16249, 18MM03110A, 18MM07198A, 18MM07209A, 18KM09546A 71335556, Lot Numbers: 18MM03107, 18MM03107A, 18MM12431, 18MM12437, 18LM13830, 18MM12440, 18JM16130, 18KM11135, 18JM16167, 18KM18727, 18MM15620, 18JM15974, 18JM15977, 18MM12430, 18JM16124, 18KM11175, 18KM04258, 18KM11126, 18JM15977A, 18LM00990, 18MM12440A, 18MM15620A, 18LM02892A, 18KM11177, 18JM18087, 18JM18087A, 18LM13844, 18LM13844A, 18MM12476, 19BM07521A, 19BM07553, 19BM07567, 18JM15968, 18JM16126, 18JM16153, 18JM16162, 18JM16171, 18JM18077, 18JM18080, 18JM18081, 18JM18086, 18JM18088, 18JM18095, 18JM18096, 18KM04256, 18KM11127, 18KM11129, 18KM11131, 18KM11158, 18KM11174, 18KM11176, 18KM11191, 18MM12432, 18MM12433, 18MM12438, 18MM12442, 18MM15598, 18MM15609, 18JM18077A, 18JM18077B, 18JM18086A, 18KM11174A, 19BM07512B, 18MM15609A, 18JM16171A, 19BM07512A 71335558, Lot Numbers: 19AM20555, 18LM09314, 18LM18593, 18LM18593A, 18JM01324, 19AM04787, 18LM09336, 18GM06066, 18GM16317, 18GM16321, 18GM16322, 18KM17664, 18KM17667, 18LM09315, 18LM09318, 18LM09319, 18LM09324, 18LM09325, 18LM09333, 18LM11687, 19am20552, 19AM20554, 19AM20559, 19AM20562, 19AM20563, 19AM20564, 19AM20577, 19AM20586, 19AM20595, 18GM16321A, 18GM16321B, 18GM16322A, 18KM17664A, 18LM09319A, 18KM17666B, 18LM09324A, 18LM09318A 71335560, Lot Numbers: 18JM01331, 18JM01331A, 18JM01330, 18JM01336, 18JM01336A, 18MM02930, 18MM02946A, 18LM09342, 18HM00793, 18JM01338, 18JM10162, 18JM10165, 18JM10166, 18JM10168, 18LM09340, 19BM12443, 18HM10463, 18HM10463A, 18HM20601
Root Cause
Process control
Action Taken
The firm notified its consignees by letter (delivered by Fed Ex) and email beginning on 04/22/2020. Consignees are asked to inspect inventory, locate and quarantine affected devices. Affected product will be returned to Smith & Nephew. Questions or concerns regarding this recall may be directed to: FieldActions@smith-nephew.com.